Research Associate, Analytical Services (Onsite laboratory)
Responsibilities
- Lead and/or perform analytical testing: HPLC/UPLC, electrophoresis, UV spectrophotometry, plate-based assays (ELISAs), cell-based bioassays, nucleic acid analysis, and compendial physicochemical assays.
- Draft/review analytical procedures; develop/review method validation protocols/reports, experimental designs, and verification/transfer protocols/reports.
- Manage/perform validation and transfer of QC methods for in-process, release, and stability testing across internal labs, CTOs, In-Country Test Labs, and partners.
- Lead/support escalated investigations to identify root cause and implement corrective/preventive actions.
- Optimize, validate, and troubleshoot methods; support maintenance of method/equipment performance.
- Trend/analyze/interprete results; conduct data review and sign-off in applicable systems.
- Support project management (timelines, stakeholder mobilization, prioritization, escalation process).
- Maintain inspection-ready lab readiness; support regulatory inspections/audits.
- Support manufacturing/QC during investigations; provide cross-functional laboratory support for GxP testing.
- Serve as SME to train analysts; support continuous improvement of lab procedures/systems.
Required Skills
- Experience with one or more analytical methods listed above and understanding of GMP/GLP requirements.
- Ability to analyze/interpret data; strong written/oral communication.
- Strong organization, multitasking, prioritization; flexibility in fast-paced environments.
Desired Skills
- Method development, qualification, and transfer experience.
- Biopharmaceutical development knowledge.
- Cross-functional experience.
Education
- Bachelorβs in Chemistry/Biochemistry/Analytical Chemistry (or related) plus 2β4 years in a biologics/pharmaceutical environment.
- Masterβs desirable (not required).
Additional Role Info
- Fully onsite; routine exposure to potential hazardous chemicals; trained on lab equipment; desktop/laptop work component; occasional non-routine hours support may be required.